The Impact of Automated Safety Document Distribution on Pharmacovigilance and Patient Safety

Dario Lirio

Imagine a patient who is taking an experimental drug as part of a clinical trial. The patient experiences an adverse reaction requiring hospitalization. They’re admitted to intensive care, which triggers a regulatory event requiring information to be transmitted to sites, ethics committees, and institutional review boards associated with the study.

Now imagine how long it would take to distribute the necessary documentation if the process to do so were manual: paper mailing and faxes, global recipients each with their own processes for receiving and processing reports, and the need to gather recipient details from a third-party clinical trial management system (CTMS).

The primary purpose of reporting during human clinical trials is to ensure patient safety. Drug developers have just seven calendar days to report life-threatening reactions—including death—and 15 calendar days to report non-life-threatening reactions to regulatory authorities. To prevent repeat serious adverse reactions during a trial, drug teams must report life- and non-life-threatening results to the regulators and investigators quickly, accurately, and efficiently.

Between 2011 and 2021, FDA has seen the number of adverse event reports it receives increase by nearly 200%. Electronic SUSAR (suspected unexpected serious adverse reactions) applications streamline and improve the drug development processes, which is especially important when time is of the essence.

As more drugs go to market more quickly, patient safety remains critical to pharmacovigilance—yet another reason beyond strengthening compliance efforts with regulators and improving oversight that the industry needs more effective, accurate reporting. Electronic SUSAR reporting platforms enable pharmacovigilance and clinical operations teams to better manage safety document distribution, in compliance with pharmacovigilance and patient safety standards, requirements and regulations.

The challenges of managing safety document distribution

Study sponsors and contract research organizations (CROs) face multiple challenges in managing safety document distribution—for example, hitting deadlines on time and with complete information—when relying on costly, labor-intensive manual processes with a higher potential to create compliance risks.

Time intensiveness

Manual processes carry many inherent risks for both pharmacovigilance and clinical operation teams, namely introducing inaccurate information throughout the entire reporting process because it involves multiple steps.

• Determining whether a serious adverse event (SAE) qualifies for expedited reporting.
• Collecting reports from the pharmacovigilance teams.
• Selecting relevant studies, investigators, institutional review boards, and ethics committees.
• Preparing and collating reports for distribution packages sent to organizations, including MedWatch and the Council for International Organizations and Medical Sciences.
• Distributing the reports via email, mail, fax, and web portals.
• Maintaining distribution records.
• Tracking receipt confirmations.
• Generating distribution reports and other documentation.

Increased cost and inefficiency

The nature of the distribution is quite costly because organizations require a significant amount of staff and manual, inefficient steps. The staff, too, become less efficient because they must conduct every part of the process by hand.Inefficiencies create longer timeframes for task completion. The more teams rely on manual steps to complete each process, the higher the opportunity for error—and the greater the cost.

Reasons to automate

If these challenges aren’t enough to convince sponsors and CROs to automate their safety document distribution, here are other reasons. Automation:

• Increases efficiency and accuracy by reducing the number of manual processes associated with the distribution process.
• Improves compliance and oversight, enabling clinical operations teams to distribute reports on time, trace the distribution and acknowledgment, generate compliance documentation and do so in a central, non-siloed location—a single source of truth.
• Facilitates the immediate distribution of expedited reports, shortening latency between a safety event’s identification and subsequent report distribution. Automation instantly transmits these safety event reports through a secure web portal to ethics committees and investigators.
• Supports organizations in meeting their good clinical practice (GCP) guidelines and improves process oversight.
• Generates cost savings by reducing both deployment and labor costs.

Two relevant use cases

Contract research organization

A large CRO identified multiple pain points. It lacked global process harmonization for safety reporting and relied on outdated, inefficient distribution methods including faxes and USPS for notifying investigators. The organization’s rapidly increasing book of business for safety reporting services meant its staff faced increased pressure.

The solution: Implementing a new safety document distribution system to streamline distribution and acknowledgment process tracking. The team inputs global distribution rules from the World Health Organization (WHO) into a single system to manage variances. The organization also implemented global safety reporting processes overseen by its pharmacovigilance department, integrating five existing regional processes into one and migrating ongoing projects into the new model. The CRO also launched a web-based secure document delivery platform specifically for investigator notification and, in doing so, saw improvements in cost, reliability, scalability, security, and traceability.

The results: After executing this project, the CRO saw multiple benefits. Its relationship with sponsor customers improved as it received positive customer feedback. Compliance rates rose, as did acceptance levels from investigators and authorities. It saw faster and more reliable solution offerings and gained more cost-effective business opportunities.

Global pharmaceutical company

A leading global pharmaceutical company managed the distribution of safety reports via its clinical operations team but had to send reports to multiple global recipients. Again, each had different preferences and expectations on how they expected report delivery, either by portal, email or fax.

The clinical team found it difficult to manage acknowledgments centrally and remain compliant. Another roadblock was the need to manually gather recipient contact details like mailing addresses and fax numbers from third-party CTMS systems to distribute reports. The process leached time and was error-prone.

The solution: The company vetted and chose an automated system that was easy to understand and use, integrated with their existing systems, and accommodated diverse distribution methods. In addition to distributing safety documents through a web portal, the automated system provides email and efax distribution options.

The results: This new safety document distribution system significantly streamlined processes and reduced costs by automating previously manual steps. It delivered consistency and enhanced traceability with its fully-validated system tracking the distribution and receipt of safety reports by individual investigators or sites. It also included enhanced security with a 24/7 accessible web-based system controlled via individual user accounts.

Effective, timely distribution of safety documents including SUSARs is critical for maintaining patient safety. Automating this process not only reduces the inefficiency of manual steps between pharmacovigilance and clinical operations teams but also enables sponsors to maintain compliance and reduce costs.

Dario Lirio, senior director, LifeSphere Clinical at ArisGlobal